[en] Background: Sugammadex rapidly reverses rocuronium-induced neuromuscular block. This study explored the dose-response relation of sugammadex given as a reversal agent at reappearance of the second muscle twitch after rocuronium and vecuronium-induced block. A secondary objective was to investigate the safety of single doses of sugammadex. Methods: in this two-center, phase II, dose-finding study, 80 patients (age >= 18 yr, American Society of Anesthesiologists physical status I or II, surgery >= 60 min requiring muscle relaxation for intubation) were randomly assigned to receive rocuronium (0.60 mg/kg) or vecuronium (0.10 mg/kg). Sugammadex or placebo was administered at reappearance of the second muscle twitch. The primary efficacy endpoint was time from starting sugammadex administration until recovery of the train-of-four ratio to 0.9. Results: Compared with placebo, sugammadex produced dose-dependent decreases in mean time to recovery for all train-of-four ratios in the rocuronium and vecuronium groups. The mean time for recovery of the train-of-four ratio to 0.9 in the rocuronium group was 31.8 min after placebo compared with 3.7 and 1.1 min after 0.5 and 4.0 mg/kg sugammadex, respectively. The mean time for recovery of the train-of-four ratio to 0.9 in the vecuronium group was 48.8 min after placebo, compared with 2.5 and 1.4 min after 1.0 and 8.0 mg/kg sugammadex, respectively. Sugammadex was well tolerated. Conclusion: Sugammadex rapidly reversed rocuronium- or vecuronium-induced neuromuscular block at reappearance of the second muscle twitch and was well tolerated. A dose-response relation was observed with sugammadex for reversal of both rocuronium- and vecuronium-induced neuromuscular block.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Suy, K.
Morias, K.
Cammu, G.
Hans, Pol ; Université de Liège - ULiège > Département des sciences cliniques > Anesthésie et réanimation
van Duijnhoven, W. G. F.
Heeringa, M.
Demeyer, I.
Language :
English
Title :
Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent
Publication date :
February 2007
Journal title :
Anesthesiology
ISSN :
0003-3022
eISSN :
1528-1175
Publisher :
Lippincott Williams & Wilkins, Philadelphia, United States - Pennsylvania
Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ: Residual neuromuscular block is a risk factor for postoperative pulmonary complications: A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand 1997; 41:1095-103
Arbous MS, Meursing AE, van Kleef JW, de Lange JJ, Spoormans HH, Touw P, Werner FM, Grobbee DE: Impact of anesthesia management characteristics on severe morbidity and mortality. ANESTHESIOLOGY 2005; 102:257-68
De Jongh K, Cammu G, Vandeput D, Vandenbroucke G, Mortier E: Clinical tests are worthless in predicting objective neuromuscular recovery (abstract). Eur J Anaesthesiol 2005; 22 (suppl 34):A127
Osmer C, Vogele C, Zickmann B, Hempelmann G: Comparative use of muscle relaxants and their reversal in three European countries: A survey in France, Germany and Great Britain. Eur J Anaesthesiol 1996; 13:389-99
Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT: Postoperative muscle paralysis after rocuronium: Less residual block when acceleromyography is used. Acta Anaesthesiol Scand 2002; 46:207-13
Mortensen CR, Berg H, el-Mahdy A, Viby-Mogensen JA: Perioperative monitoring of neuromuscular transmission using acceleromyography prevents residual neuromuscular block following pancuronium. Acta Anaesthesiol Scand 1995; 39:797-801
Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T: Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg 2006; 102:426-9
Caldwell JE: Reversal of residual neuromuscular block with neostigmine at one to four hours after a single intubating dose of vecuronium. Anesth Analg 1995; 80:1168-74
Bom A, Bradley M, Cameron K, Clark JK, van Egmond J, Feilden H, MacLean EJ, Muir AW, Palin R, Rees DC, Zhang MQ: A novel concept of reversing neuromuscular block: Chemical encapsulation of rocuronium bromide by a cyclodextrin-based synthetic host. Angew Chem Int Ed Engl 2002; 41:266-70
de Boer HD, van Egmond J, van de Pol F, Bom A, Booij LH: Chemical encapsulation of rocuronium by synthetic cyclodextrin derivatives: Reversal of neuromuscular block in anaesthetised Rhesus monkeys. Br J Anaesth 2006; 96:201-6
Khuenl-Brady K, Rex C, Sielenkämper A, Kjaer CC, Eikermann M, Larsen PB, Prins ME, Pühringer F: Reversal of high-dose rocuronium with Org 25969 (abstract). Eur J Anaesthesiol 2005; 22 (suppl 34):A458
Shields M, Giovannelli M, Mirakhur RK, Moppett I, Adams J, Hermens Y: Org 25969 (sugammadex), a selective relaxant binding agent for antagonism of prolonged rocuronium-induced neuromuscular block. Br J Anaesth 2006; 96:36-43
Gijsenbergh F, Ramael S, Houwing N, van Iersel T: First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. ANESTHESIOLOGY 2005; 103:695-703
Vanacker BF, Vermeyen KM, Struys MRF, Rietbergen H, Vandermeersch E, Saldien V, Kalmar AF, Prins ME: Reversal by Org 25969 is not affected by sevoflurane compared with propofol (abstract). Eur J Anaesthesiol 2005; 22 (suppl 34):A453
Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Østergaard D, Prins ME, Viby-Mogensen J: Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent, sugammadex: A dose-finding and safety study. ANESTHESIOLOGY 2006; 104:667-74
Hope F, Bom A: Rapid reversal of vecuronium induced block with sugammadex in three species (abstract). Eur J Anaesthesiol 2006; 23 (suppl 37):A535
Van den Broek L, Proost JH, Wierda JM: Early and late reversibility of rocuronium bromide. Eur J Anaesthesiol 1994; 11 (suppl 9):128-32
Hunter JM: New neuromuscular blocking drugs. N Engl J Med 1995; 332:1691-9